Medical device licence · 80721 · Class 2
SOLAR BLUE URODYNAMICS SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed September 21, 2009; ended April 15, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 80721
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 21, 2009
- Ended
- April 15, 2015
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOLAR BLUE - BIOFEEDBACK SOFTWARE
- SOLAR BLUE - CATHETER PULLER
- SOLAR BLUE - POWER CABLE
- SOLAR BLUE - RECHARGEABLE BATTERY PACK MODULE
- SOLAR BLUE - REMOTE CONTROL
- SOLAR BLUE - REX (REPAIR EXCHANGE) MODULE
- SOLAR BLUE - REX FLOWMETER
- SOLAR BLUE - REX LAPTOP
- SOLAR BLUE - REX PUMP HEAD
- SOLAR BLUE - REX SAFETY MODULE
- SOLAR BLUE - SOFTWARE REPLACEMENT
- SOLAR BLUE - WIRELESS CATHETER PULLER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.